AOI CRANIAL HELMET— 510(k) K103362

Substantially Equivalent

Advanced Orthopro, Inc.

FDA 510(k) clearance K103362 for AOI CRANIAL HELMET, Substantially Equivalent on 2011-04-18. Applicant: Advanced Orthopro, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Orthopro, Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2010-11-17
Decision date: 2011-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.